Skip to main content
OpenTrials
Completed

NCT Number: NCT02219399

DHA Supplementation and Pregnancy Outcome

Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Hospitals and Clinics, Denver, Colorado, United States

Loading trial locations.

About this study

This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnancy
  • 18 years of age or older

Exclusion criteria

  • cervical incompetence
  • presence of cervical cerclage
  • placenta previa
  • intrauterine infection
  • known substance abuse
  • multiple fetuses
  • current pre-eclampsia
  • preexisting diabetes

Treatment and study plan

600 mg DHA

Dietary Supplement

Pregnant women were given 600 mg DHA in the last trimester of pregnancy

300 mg DHA

Dietary Supplement

Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding

Placebo

Dietary Supplement

Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period

Primary outcomes

  1. Gestational Length

    Time frame: 13 weeks

    Length of gestation as measured by Last menstrual period method and US

  2. Cognitive Development

    Time frame: 4 months

    Bayley's Scales of Infant Development measured at 4 months of age

  3. Cognitive Development

    Time frame: 12 months

    Bayley's Scales of Infant Development measured at 12 months of age

Secondary outcomes

  1. Infant birth length

    Time frame: 13 weeks

    self-explanatory

  2. Infant Growth Velocity

    Time frame: 2 months to 4 months of age

    Change in infant length and weight from 2 to 4 months of age

  3. Infant birth weight

    Time frame: 13 weeks

    self-explanatory

  4. Infant head circumference at birth

    Time frame: 13 weeks

    self-explanatory

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

Maternal DHA Supplementation and Pregnancy Outcome

Important dates

Study start
2001
Primary completion
2004
Study completion
2014
First posted
Aug 18, 2014
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.